Overview

Intranasal ALN-RSV01 Administered to Adult Volunteers Experimentally Inoculated With Respiratory Syncytial Virus

Status:
Completed
Trial end date:
2007-11-01
Target enrollment:
0
Participant gender:
Male
Summary
The purpose of this study is to determine the safety, tolerability and efficacy of intranasal ALN-RSV01 versus placebo, administered once daily for 5 days to a healthy male volunteers experimentally inoculated with RSV
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Alnylam Pharmaceuticals
Criteria
Inclusion Criteria:

- Availability for the required study period (including the inpatient phase, ability to
comply with study requirements and attend follow-up study visits

- Able to provide written consent for participation after reading the Consent Form and
after having adequate opportunity to discuss the study with an investigator or
qualified deputy.

- Good general health status as determined by a screening evaluation no greater than 120
days but not less than 14 days prior to enrollment and admission to the research unit

- Low titers of RSV neutralizing antibody measured during screening.

Exclusion Criteria:

- Significant acute or chronic, uncontrolled medical illness

- Presence of household member or close contact to someone who:

- Is less than three(3) years of age

- Has a known immunodeficiency

- Is receiving immunosuppressant drugs

- Is undergoing or soon to undergo cancer chemotherapy within 28 days of enrollment

- Has diagnosed emphysema, chronic obstructive pulmonary disease(COPD), or severe
lung disease

- Is elderly and residing in a nursing home, or

- Has received an organ transplant

- Females are not eligible for this study

- Evidence of or history of drug or alcohol abuse (within the past 6 months) or positive
urine drug or alcohol screen

Other protocol-defined inclusion/exclusion criteria may apply.